Patient DischargeNCT01207180
Discharge Planning for Elderly Patients in the Emergency Department: Use of a Brief Phone Call After Discharge to Improve Medication Utilization and Physician Follow-up
A study testing Phone call follow-up and Satisfaction survey in people with Patient Discharge, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The investigators hypothesize that the acquisition and correct utilization of medications as well as arranging and attending follow-up appointments will improve as a result of a phone call intervention 1-3 days after elderly patients are discharged from the emergency department (ED). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Patient Discharge
- What is being tested?
- Phone call follow-up and Satisfaction survey
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 157 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Nov 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 or over
- Discharged from the UNC emergency department
Who cannot join
- In the hospital at the time of phone call follow-up
- Neither the patient nor their responsible party are able to pass a standardized test to assess cognitive function
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina Emergency Department
Chapel Hill, North Carolina, 27599
About this study
The investigators hypothesize that the acquisition and correct utilization of medications as well as arranging and attending follow-up appointments will improve as a result of a phone call intervention 1-3 days after elderly patients are discharged from the emergency department (ED).
Read the detailed description
Older patients seen in the ED are at high risk of functional decline and return visits to the ED. Previous studies have shown that a comprehensive assessment by a geriatric specialist at the time of discharge from the ED along with extensive integration with home services and/or referral to community services can decrease functional decline and return visits to the ED as well as increase patient satisfaction, but this intervention is resource intensive requiring a geriatric discharge specialist to be available to the emergency department 24 hours a day/ 7 days a week. It is also known that in other patient populations telephone reminders to make follow up appointments can increase rate of follow up and that comprehension of discharge instructions is the primary barrier to compliance with discharge instructions. It has been shown that telephone follow-up interviews are feasible for geriatric patients discharged from the ED, and that many elderly patients discharged from the ED do not understand their discharge instructions or attend follow-up appointments. However, there are no published studies evaluating whether a follow up telephone call after discharge from the ED can improve patient compliance with the medical treatment plan including obtaining follow - up appointments and obtaining prescribed medications as well as using them appropriately. We seek to determine if we can increase compliance with medications and outpatient follow up with a phone call from a nurse provider 1-3 days after discharge.
- Conditions
- Patient Discharge
- Being tested
- Phone call follow-up, Satisfaction survey, Control group --- no intervention
- Keywords
- emergency medicine, primary care physicians
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone call follow-upOther
A nurse will call the patient to counsel patients on their medications and following up with their primary care provider.
Satisfaction surveyOther
Patients will be given a satisfaction survey.
Control group --- no interventionOther
Control group
| Study group | Role | What they receive |
|---|---|---|
| Follow-up phone call from Nurse | Experimental | Patients in this are will receive a phone call follow-up from a nurse 1-3 days after their discharge from the ED. Receives: Other: Phone call follow-up |
| Satisfaction survey | Placebo comparator | This group of patients will receive a phone call from a student who will conduct a brief satisfaction survey of the patient's experience in the ED. Receives: Other: Satisfaction survey |
| Control group | Placebo comparator | Patients in this group will receive no phone call at 1-3 days. Receives: Other: Control group --- no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether patient obtained medications prescribed at their discharge from ED
Measured: 5-8 days after discharge from ED
Whether patient is using medications that were prescribed at their ED discharge correctly
Measured: 5-8 days after discharge from ED
Whether the patient arranged a follow-up appointment with their primary care provider
Measured: 5-8 days after discharge from ED
Whether patient attended visit with their primary care provider after discharge from the ED
Measured: 30-35 days after discharge from ED
Secondary outcomes (3)
Patient's satisfaction with ED visit
Measured: 5-8 days after discharge from the ED
Return to the ED within 30 days of initial visit
Measured: 30-35 days after discharge from ED
Cost of the intervention
Measured: 35 days after last patient enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient DischargeStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- The Duke Endowment
- Responsible party
- Principal investigator, Kevin Biese, MD, University of North Carolina, Chapel Hill
- Investigators
- Kevin J Biese, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01207180
- Sponsor's protocol ID
- 10-0978
- Status last verified
- Nov 2011
- First submitted
- 13 Sep 2010
- Last updated
- 18 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Biese K, Lamantia M, Shofer F, McCall B, Roberts E, Stearns SC, Principe S, Kizer JS, Cairns CB, Busby-Whitehead J. A randomized trial exploring the effect of a telephone call follow-up on care plan compliance among older adults discharged home from the emergency department. Acad Emerg Med. 2014 Feb;21(2):188-95. doi: 10.1111/acem.12308.
PubMed 24673675
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discharge Planning for Elderly Patients in the Emergency Department: Use of a Brief Phone Call After Discharge to Improve Medication Utilization and Physician Follow-up
- ClinicalTrials.gov ID
- NCT01207180
- Acronym / sponsor ID
- 10-0978
- Conditions
- Patient Discharge
- Keywords
- emergency medicine, primary care physicians
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- The Duke Endowment
- Study start
- Sep 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 22 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesize that the acquisition and correct utilization of medications as well as arranging and attending follow-up appointments will improve as a result of a phone call intervention 1-3 days after elderly patients are discharged from the emergency department (ED).
Detailed description
Older patients seen in the ED are at high risk of functional decline and return visits to the ED. Previous studies have shown that a comprehensive assessment by a geriatric specialist at the time of discharge from the ED along with extensive integration with home services and/or referral to community services can decrease functional decline and return visits to the ED as well as increase patient satisfaction, but this intervention is resource intensive requiring a geriatric discharge specialist to be available to the emergency department 24 hours a day/ 7 days a week. It is also known that in other patient populations telephone reminders to make follow up appointments can increase rate of follow up and that comprehension of discharge instructions is the primary barrier to compliance with discharge instructions. It has been shown that telephone follow-up interviews are feasible for geriatric patients discharged from the ED, and that many elderly patients discharged from the ED do not understand their discharge instructions or attend follow-up appointments. However, there are no published studies evaluating whether a follow up telephone call after discharge from the ED can improve patient compliance with the medical treatment plan including obtaining follow - up appointments and obtaining prescribed medications as well as using them appropriately. We seek to determine if we can increase compliance with medications and outpatient follow up with a phone call from a nurse provider 1-3 days after discharge.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Follow-up phone call from Nurse | Experimental | Other: Phone call follow-upPatients in this are will receive a phone call follow-up from a nurse 1-3 days after their discharge from the ED. |
| Satisfaction survey | Placebo comparator | Other: Satisfaction surveyThis group of patients will receive a phone call from a student who will conduct a brief satisfaction survey of the patient's experience in the ED. |
| Control group | Placebo comparator | Other: Control group --- no interventionPatients in this group will receive no phone call at 1-3 days. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age 65 or over
- Discharged from the UNC emergency department
Key exclusion criteria (2 listed)
- In the hospital at the time of phone call follow-up
- Neither the patient nor their responsible party are able to pass a standardized test to assess cognitive function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phone call follow-upA nurse will call the patient to counsel patients on their medications and following up with their primary care provider. | Other | Follow-up phone call from Nurse |
| Satisfaction surveyPatients will be given a satisfaction survey. | Other | Satisfaction survey |
| Control group --- no interventionControl group | Other | Control group |
Primary outcome
Whether patient obtained medications prescribed at their discharge from ED
Time frame: 5-8 days after discharge from ED
Whether patient is using medications that were prescribed at their ED discharge correctly
Time frame: 5-8 days after discharge from ED
Whether the patient arranged a follow-up appointment with their primary care provider
Time frame: 5-8 days after discharge from ED
Whether patient attended visit with their primary care provider after discharge from the ED
Time frame: 30-35 days after discharge from ED
3 secondary outcomes
Patient's satisfaction with ED visit
Time frame: 5-8 days after discharge from the ED
Return to the ED within 30 days of initial visit
Time frame: 30-35 days after discharge from ED
Cost of the intervention
Time frame: 35 days after last patient enrolled
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2011.
- Derived from this study: PubMed 24673675Biese K, Lamantia M, Shofer F, McCall B, Roberts E, Stearns SC, Principe S, Kizer JS, Cairns CB, Busby-Whitehead J. A randomized trial exploring the effect of a telephone call follow-up on care plan compliance among older adults discharged home from the emergency department. Acad Emerg Med. 2014 Feb;21(2):188-95. doi: 10.1111/acem.12308.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin J Biese, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phone call follow-up and Satisfaction survey in people with Patient Discharge, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whether patient obtained medications prescribed at their discharge from ED (time frame: 5-8 days after discharge from ED). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01207180, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2011.